Precedex

Hospira, Inc.🇺🇸 United States

FDA Page

Effective Date: May 20, 2026
Approval ID: 548a88c0-afda-427e-75ac-5af0cfa2224c
Products: 7 registered
Version: 59

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PRECEDEX safely and effectively. See full prescribing information for PRECEDEX. PRECEDEX™ (dexmedetomidine hydrochloride) injection, for intravenous use PRECEDEX™ (dexmedetomidine hydrochloride) in sodium chloride injection, for intravenous use Initial U.S. Approval: 1999

Quick Stats

Total Products7

Labelers2

Label Sections52

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.